ISPE NORDIC are pleased to invite you
to our upcoming conference
GDP, Packaging and Serialization
Date and Venue
19 September 2013
Scandinavian Trade Building, Gydevang 39-41, Alleroed (Copenhagen)
Who should attend?
Process Engineers, Quality Engineers and Project Managers, working with the subjects.
We hope that you will book your calendars now, and remember to register for the event soon as seats
are limited.
For seminar registration, please click here.
If you have any questions regarding the seminar or registration, please contact:
Anders Brummerstedt, +45 2332 5872, abru@pec.dk
Programme
8:00 - 8:30
Coffee, Registration
8:30 - 8:45
Welcome (Anders Brummerstedt, ISPE Nordic)
9:00 - 10:00
Setting the Scene – GDP – Regulation – Trends (Lars Olsen, NNE
Pharmaplan)
10:00 - 10:30
Networking Break
10:30 - 11:30
Experiences with the Implementation of Online Print (Henrik Broholm,
Lundbeck)
11:30 - 12:30
Productivity and Efficiency – Practical Implementations (Hans Harborg,
Bifodan)
12:30 - 13:30
Lunch
13:30 - 14:30
Late Stage Customization – The Final Step in Operational Excellence (James
MacKenzie, HAPA)
14:30 - 15:00
Networking Break
15:00 - 16:00
A Sense of Urgency – Are You Ready to Meet the Track & Trace Deadline
for Codification / Serialization (Hendrik Kneusels, Laetus)
16:00 - 16:30
Closing Comments, PacLaW (Lars Olsen / Anders Brummerstedt)
Programme Content – Details
Lars Olsen, NNE Pharmaplan:
GDP – Regulation – Trends
 GDP Overview
 Serialization versus Codifications
 Stakeholders in Pharma Coding
 The Impact of Automated Identifiers
 A Codification Project at a Glance
 World Class Pharmaceutical Packaging
Hans Harborg, Bifodan:
Improvement of Productivity and Quality at Bifodan on a Low Budget
Bifodan A/S is a small pharmaceutical company specialized in products with lactic bacteria. The
pharmaceutical dosage forms are mainly hard shell capsules and tablets. These dosage forms are
packed in plastic bottles, aluminium tubes and plastic blisters. Bifodan A/S has succeeded with
improving quality and productivity in packaging processes with very limited financially financial
resources. This presentation will show some of the improvements. The strategies for identifying the
improvements are identified and the effects of the improvements are also shown. Some of the
improvements have been designing and building of robots. Some of the improvements have been
new design of packaging lines, and others have been implementing standard control equipment.
Bifodan has in parallel started working improvement of the supply chain. The activities in the supply
chain for each individual order are recorded and coordinated between the different departments.
James MacKenzie, HAPA:
Outlining the Final Step in Operational Excellence
 Summarising the manufacturing and supply chain challenges in the healthcare industry
 Exploring how on line printing leads to improved performance and profitability
 Understanding late stage customisation, core technologies and key applications
 Discussing methods to address the seven forms of waste
Hendrik Kneusels, Laetus:
A Sense of Urgency – Are You Ready to Meet the Track & Trace Deadlines?
While the growing number of regulations and laws are increasing the pressure on the Pharmaceutical
industry to implement Track & Trace measures and thus to become compliant, the true value and
ultimate driver for the sizeable investments it takes, should still be the “Health and Wellbeing of the
Patient”.
By the way, a core value that we find in almost all of the big companies Vision or Mission statements!
The WHO (World Health Organization) estimates that 12% of drugs are counterfeit, with this
percentage rising to 65% in developing countries.
About the Speakers
Lars Olsen, NNE Pharmaplan
Lars is a Senior Consultant and Subject Matter Expert on Serialization, with
more than 25 years of experience
Henrik Broholm, Lundbeck
Senior Specialist, Pharmaceutical Engineering
5 years as external consultant in the Pharmaceutical industry within
technical sales/troubleshooting/commissioning, FAT at vendors, SAT at
customers, validation.
12 years at H. Lundbeck A/S, supporting mainly Finished Goods
Production in DK, France, Mexico and occasionally China.
Specifying and purchasing of Packaging lines, heading validation activities
Member of several Packaging launch groups.
Equipment responsible for T&T activities all sites.
Hans Harborg, Bifodan
Hans Harborg is M Sc. Pharm. From Royal Danish School of Pharmacy.
Before joining Bifodan Hans Harborg has worked for more than 20 years
with production in various major pharmaceutical companies, like Ferring
Pharmaceuticals, Novo Nordisk and Orion Pharma.
Hans Harborg has been production manager in Bifodan for 7 years. His
responsibility in the current position includes activities from receiving
customer orders until delivery and invoicing. This also includes
responsibility for warehousing, technical department and managing subcontractors.
In Bifodan Hans has also been responsible for improvement projects like
expanding the site, installation of new production equipment, process
validation in cooperation with customers as well as setting up new
processes.
James MacKenzie, HAPA
Based in Zurich, James is Commercial Director at Hapa AG and is
responsible for Global sales. He holds an Engineering degree gained in his
home city of Liverpool, England, and has worked in the pharmaceutical
Industry for nearly 20 years. He has sound expertise in pharmaceutical
process and packaging machinery and specializes in helping
manufacturers achieve operational excellence with a focus on production
and supply chain processes.
Dirk Hendrik Kneusels, Laetus
Commercial Director and Business Development, Laetus GmbH
After Dirk Hendrik Kneusels completed his studies of applied physics in
Wiesbaden, Germany, he entered into the business of packaging security.
As a developer he invented such products as optical control devices for
primary and secondary packaging materials as well as initial tools and
systems for packaging line optimization.
Based on his sound knowledge and due to his ability to describe complex
solutions in an easily comprehensible way, he first moved into project
management and ultimately into sales.
His efforts and initiatives were followed by a successful expansion of his
know-how within the fields of packaging security and Pharma specific
requirements.
He then became the Managing Director of Laetus GmbH with the
responsibility for implementing a new organizational structure and
efficiency increases for the international Laetus group.
The latest step in his professional career occurred when he became
Commercial Director as which he is now in charge of all customer related
activities and business development.